Director, Regulatory Affairs Advertising and Promotion

Role Summary

Director, Regulatory Affairs Advertising and Promotion. Reports to the Senior Director, Regulatory Affairs Advertising and Promotion and is responsible for reviewing and approving advertising and promotional or medical communications to ensure compliance with regulations, policies and procedures. The role will serve as a regulatory reviewer on Medical, Legal, Regulatory (MLR) and/or Medical Review Committee (MRC) teams and will support Crinetics’ commercialization and future marketed products. Location: San Diego, CA.

Responsibilities

• Review medical education and commercial advertising and promotional materials, including disease state and training/education programs to ensure materials comply with applicable regulatory requirements, laws, and guidelines.
• Serve as a regulatory reviewer on the Medical, Legal, Regulatory (MLR) committee and/or Medical Review Committee (MRC) teams or other promotional review committees.
• Serve as back-up contact with the FDA Office of Prescription Drug Promotion (OPDP).
• Work with Regulatory Operations, assist with 2253 submissions.
• Monitor competitor advertising and promotion materials.
• Provide strategic input on campaigns for compliant product communications that meet program and corporate objectives.
• Identify MLR/MRC process or system improvements (such as Veeva).
• Articulate complex regulatory issues to project teams and external stakeholders to support global development and commercialization of drug candidates.
• Implement strategies to ensure programs are within the framework of published guidance documents and identify areas of risk.
• Assist with managing budgets for the functional area.
• Translate business needs into strategic initiatives and drive quantifiable outcomes for the Regulatory Affairs Advertising and Promotion group, focusing on immediate and short-term (<2 years) planning horizon.
• Develop relationships with external parties (e.g., CROs, consultants) and stay current on industry trends and practices.
• Set high standards on deliverables while managing risks and timelines.
• Provide guidance, tutoring, and training to staff as necessary.
• Other duties as assigned.

Qualifications

• Required: Minimum of 12 years with a Bachelor's, or 10 years with an MS/PhD of relevant Regulatory Affairs experience in a biotech/pharmaceutical setting with a proven record of significant regulatory experience and accomplishments.
• Required: Minimum of 8 years supervisory experience.
• Required: Equivalent combination of relevant education and applicable job experience may be considered.
• Required: Thorough knowledge of FDA advertising and promotion regulations and guidance as well as current industry and health authority trends and expectations.
• Required: Experience with MLR or promotional review committees supporting product communications and managing regulatory submissions of promotional materials.
• Required: Experience and understanding of International Conference on Harmonization (ICH) and FDA regulations.
• Required: Prior experience working at a small company with wide-ranging related responsibilities is desired.
• Required: Excellent negotiation skills and a tactful approach that leads to high value on outcomes achieved.
• Required: Excellent written and oral communication skills.
• Required: Strong organizational skills, including the ability to prioritize workload.
• Required: Ability to meet deadlines and perform multiple tasks in a fast-paced setting.
• Required: Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint). Knowledge of other software required: Advanced MS Word and Adobe PDF knowledge.
• Preferred: Experience interpreting and applying local regulations and guidance for drug development from early R&D through commercialization.
• Preferred: Software Knowledge: Electronic document management systems use (e.g., Veeva PromoMats) highly desired. Publishing experience and/or eCTD knowledge is desired (Lorenz, GlobalSubmit, eCTDExpress, etc.).

Education

• Bachelor’s or MS/Ph.D. degree in a scientific area.

Additional Requirements

• Travel: You may be required to travel up to 5% of your time.
• Physical Demands: Sit for long periods at a desk; occasional walking and lifting up to 25 lbs; reasonable accommodations available as needed.